A prospective, observer-blind, randomized clinical trial to investigate and compare the clinical efficacy of Chloroprocaine 3% gel and Oxybuprocaine 0.4% eye drops anesthesia for clinical practice in pediatric population.
This study is comparing two different eye numbing gels, Chloroprocaine 3% and Oxybuprocaine 0.4%, for use in children aged 0-17. These gels are used to make eye exams more comfortable by numbing the surface of the eye. The main goal is to see which gel is better at numbing the eye effectively, specifically testing the right eye five minutes after applying the gel. Researchers will also be carefully watching for any side effects or discomfort the children might experience with either gel. This is a vital step in ensuring eye procedures are as pain-free and safe as possible for young patients.
At a glance
What is this study about?
Imagine you need to have your eyes checked by a doctor, and sometimes a little numbing gel is used to make it more comfortable. This study is like a careful test to see which numbing gel works best for children, from babies right up to teenagers (ages 0-17).
Doctors want to find out if Chloroprocaine 3% gel or Oxybuprocaine 0.4% eye drops do a better job of numbing the surface of the eye before an eye exam. They will put the gel in one eye and then, after about five minutes, check to make sure it's numb enough for the examination. This helps ensure that children don't feel uncomfortable during their eye check-up.
Besides checking how well the gels numb the eye, the study is also very focused on safety. The doctors and nurses will be looking closely for any redness, swelling, or other unexpected reactions in the eye. They'll also ask how the child (if old enough) or their parents feel about how well the gel was tolerated overall. The aim is to find the safest and most effective way to numb a child's eye when needed.
Key takeaways
- Compares two eye numbing gels for children aged 0-17.
- Aims to find the most effective and safest numbing gel for eye exams.
- Involves a single visit during your child's scheduled eye appointment.
- Safety and comfort of your child are top priorities.
- Your decision to participate is voluntary and can be changed.
Who may be eligible?
This study is looking for children and young people who need to have an eye exam where numbing drops or gel are usually used. Both boys and girls can take part.
To be eligible, the child must be between 0 and 17 years old and be coming to the clinic for a routine eye check-up where numbing of the eye's surface is planned. They must be outpatients, meaning they come to the clinic for their appointment and don't stay overnight.
There aren't many restrictions, so if your child needs an eye exam that involves numbing, they might be a good fit for this study.
- Is your child an outpatient (attends clinic, not staying overnight)?
- Is your child aged between 0 and 17 years old?
- Does your child need an eye exam where numbing eye drops are normally used?
- Is your child male or female? (Both can join).
This is a guide only — the research team will confirm whether you can take part.
What does participation involve?
If your child takes part in this study, they will have one of the two numbing eye gels put in their right eye just before their eye exam. The study team will then check to see how well the eye is numbed. Throughout the study visit, the doctors will carefully watch for any changes in your child's eye, such as redness or swelling, and ask about any discomfort.
The overall visit will likely be similar in length to a standard eye exam appointment, with a little extra time for the study team to observe and record information. You won't need to return for extra visits specifically for the study after your child's initial eye exam.
Potential risks and benefits
Locations (1)
- —Italy
Common questions
What is the main goal of this study?
The main goal is to find out which numbing eye gel works better and more safely for children having eye exams.
Will my child definitely get a numbing gel?
Yes, if your child is in the study, they will receive one of the two numbing eye gels being tested in their right eye.
What kind of eye exams are we talking about?
This study is for children who need a regular eye check-up where numbing of the eye's surface is usually done.
Will my child be safe in this study?
Yes, doctors and nurses will closely watch your child for any side effects or discomfort throughout the study.
Can I change my mind about my child participating?
Yes, you can withdraw your child from the study at any time, and it won't affect their regular medical care.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
Discussion
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